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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA063650-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.
This project seeks to develop a culturally adapted Contingency Management (CM) intervention for Black adults with stimulant use disorder (StUD). CM is grounded in behavioral economics and involves the use of tangible positive reinforcements to incentivize verifiable pro-health behaviors. There has been a recent surge in fatal stimulant related drug overdoses in the Black community. Black adults in the United States have been experiencing faster rates of overdose deaths, with a rate of 49.5/100,000 in 2022 (1.4 times the rate among White Americans). A resurgence in stimulant use, contamination of community drug supplies with high potency synthetic opioids (HPSO) and a range of structural and social vulnerabilities are major drivers of this unfortunate trend. CM has been shown to be the most effective intervention for StUD as there are no FDA approved medications for this indication. Emerging evidence shows that Black adults who entered treatment with cocaine-positive urines did not show any gains in treatment retention or other clinical outcomes. This observation of disparate health outcomes has informed the urgency to culturally adapt CM for Black population which is at heightened risk given the opioids/stimulant polysubstance fatal overdose.
The objective of this research is to develop components of a culturally adapted CM using theoretically and empirically driven approaches. Specific research aims include: 1) Assessment of the target population's behavioral risks, perceived need for prevention, barriers, preferences for intervention and development of components of CM adaptation; 2) production of iterative drafts of the adapted CM and 3.) Pilot randomized controlled trial to examine the short-term efficacy of the adapted CM with the primary outcomes of percent negative urines and longest duration of abstinence during treatment. Aim 3 consists of PI training to deliver the culturally adapted treatment and the culturally adapted treatment will be piloted with the community that the treatment was adapted for over 12 weeks, twice weekly, with a 4 week lead-in phase.
Aims 1 and 2 are Observational aims not requiring registration that will inform Aim 3.
The focus of this registration is Aim 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally Adapted CM | Experimental | Participants in this arm will receive the culturally adapted CM over a 12- week treatment period |
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| Basic CM | Experimental | Participants in this arm will receive the basic CM over a 12- week treatment period |
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| Standard Care Condition | No Intervention | Intensive Outpatient clinic (IOP) at substance use treatment and addiction (SATU) clinic twice every week, one day for group and the other for individual counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultually Adapted Contingency Management (CM) | Behavioral | Same protocol as basic CM with adaptations incorporated. The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent negative urine samples | Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated. | Week 12 |
| Mean longest duration of abstinence | The longest duration of abstinence in days will be measured. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean treatment retention | Treatment retention in days will be measured. | Baseline and Week 12. |
| Acceptability of Intervention Measure (AIM) | Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability.Total score 1-5 with higher scores indicating greater acceptability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwole Jegede, MD, PhD | Contact | 203-974-7096 | Oluwole.jegede@yale.edu | |
| Alexander Alario, PhD | Contact | 203-903-4603 | Alexandra.alario@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oluwole Jegede, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center (CMHC) | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42419893 | Derived | Jegede OO, Becker SJ, Iheanacho T, Bellamy C, Petrakis I, Kiluk B, Rash C. Rationale, design and methods of the Cul-CM study: a protocol for cultural adaptation of contingency management in adults with stimulant use disorder. BMJ Open. 2026 Jul 8;16(7):e120424. doi: 10.1136/bmjopen-2026-120424. |
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Participants are adults with stimulant use disorder who identify as Black/African American.
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| Basic Contingency Management (CM) | Behavioral | An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks |
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| Week 12 |
| Feasibility of Intervention Measure (FIM) | Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility. | Week 12 |
| Client Satisfaction Questionnaire (CSQ-8) | An 8-item, self-report measure developed to assess global satisfaction with health and behavioral health services. Each item is rated on a 4-point Likert scale, producing total scores ranging from 8 to 32, with higher scores indicating greater satisfaction. The instrument evaluates perceived quality of care, extent to which services met the client's needs, overall benefit, and willingness to recommend the service | Week 12 |